Remedy Skin Protectant

Product NDC: 53329-302
11-digit product format: 533290302
Labeler code: 53329
Product ID: 53329-302_efcfa488-6020-fcbd-e053-2995a90ad540
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-11-06
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 59 g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-302		D	Discontinued by firm	2026-11-13
excluded package	package	53329-302	53329-302-14	D	Discontinued by firm	2026-11-13
excluded package	package	53329-302	53329-302-41	D	Discontinued by firm	2026-11-13

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-302-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-302-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-302-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-302-14	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ALUMINUM STEARATES	INACTIVE INGREDIENT	O4D7U3B46U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PENTAERYTHRITYL DISTEARATE	INACTIVE INGREDIENT	697WOT8HNB	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-302	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES, LP]	6	Legacy NDC	20241207_0ec52309-642f-4667-9199-6711190fa1d4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 66 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-302-14	53329030214	57 g in 1 TUBE (53329-302-14)	57 g	2013-11-06	0000-00-00	No	No	Current
53329-302-41	53329030241	169.5 g in 1 TUBE (53329-302-41)	169.5 g	2013-11-06	0000-00-00	No	No	Current